The need is known in the field of CPAP devices, systems and methods, and in particular, of a CPAP compliance apparatus and method to be able to detect a signal of a patient's instantaneous presence upon a supporting substrate while in simultaneous consideration able to detect a signal of changes in air pressure through an air pressure tube remotely positioned from the airways of the patient so as to employ such signals to a compliance notification controller unit adapted to provide the patient receiving the CPAP treatment an alert at the end limit of a time delay off-time relating to the patient's initial lodging of a mask or re-lodging of the patient's CPAP mask in the event the CPAP mask has become dislodged during CPAP treatment utilized for treatment of sleep apnea with the purpose of delivering of continuous positive airway pressure to the patient so that the patient is compliant with his/her physician's prescribed CPAP treatment.
Apnea is a sleep disorder characterized by abnormal pauses in breathing or instances of abnormally low breathing during sleep. According to Sleep Medical Review, Continuous Positive Airway Pressure (CPAP) therapy is the gold standard treatment for people diagnosed with sleep apneas. CPAP is an acronym for “continuous positive airway pressure”, which was developed by Dr. George Gregory and colleagues in the neonatal intensive care unit at the University of California, San Francisco (Gregory G A; Kitterman J A; Phibbs R H; Tooley W H; Hamilton W K (Jun. 17, 1971). “Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. The New England Journal of Medicine 284 (24): 1333-40. ISSN 0028-4793. LCCN 20020456. OCLC 231027780. PMID 4930602. Retrieved 2015-03-22).
Sleep Apnea is a breathing disorder that occurs during periods of sleep. The Greek word “apnea” means “without breath”. It is intermittent cessation of ventilation during sleep that results in a decrease in blood oxygen levels, a decrease in heart rate, and resultant illnesses such as cardiac arrhythmias, hypertension, heart disease, and/or heart failure. The consequences of sleep apnea are evident throughout the waking hours, and include sleepiness, non-attentiveness, headaches, memory problems, weight gain, safety-related accidents, personality disturbances, and other sleep-deprivation related afflictions. The causes of the various forms of sleep apnea are not fully understood. There are three general types of sleep apnea or Sleep Disordered Breathing (SDB): Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA) and Mixed Sleep Apnea.
Obstructive sleep apnea results from a blockage or occlusion of the oropharyngeal (upper) airway. With obstructive sleep apnea, respiratory functions continue, but blockage or occlusion of the airway results in reduced or halted airflow. Obstructive sleep apnea syndrome is indicated by a narrowing of the upper airway, resulting in a progressive asphyxia that continues until the individual is briefly woken from sleep, which restores airway patency and airflow through the upper airway. These frequent arousals, although necessary for proper airway ventilation to resume, deprive the individual from restorative deep sleep. These partial awakenings throughout sleep result in both mental and physical strain on the individual. Obstructive sleep apnea is the most common form of sleep apnea.
Central sleep apnea results from the brain failing to signal the muscles to breathe. The neural drive to the respiratory muscles discontinues for a brief period of time. These transients may continue throughout the night for periods from ten seconds to as long as 2 to 3 minutes. Often time individuals with central sleep apnea have a history of pulmonary hypertension, heart disease or heart failure, respiratory problems, or polycythemia. Central sleep apnea, similar to obstructive sleep apnea, causes a gradual asphyxiation during sleep, resulting is a brief arousal from sleep, at which time the individual's respiratory function returns to normal. consequences of central sleep apnea during the waking hours is similar to those of obstructive sleep apnea, and include sleepiness, non-attentiveness, headaches, memory problems, weight gain, safety-related accidents, personality disturbances, and other sleep-deprivation related afflictions.
In sum, the sleeper who suffers from OSA periodically struggles to breathe but is unable to inhale effectively because his or her airway has collapsed. The sleeper whose problem is CSA periodically doesn't breathe at all, or breathes so shallowly that oxygen intake is ineffectual. In either type of sleep apnea, the lack of oxygen usually causes the patient to wake up, at least briefly.
There are several known treatments for sleep apnea. They consist of physical or mechanical treatments, surgery, and attempts at pharmacological treatment. The treatment regimen is tailored to the individual, and is based on the medical profile of the patient being treated.
The most common effective treatment for patients with sleep apnea is continuous positive airway pressure (CPAP). The purpose of the CPAP device is to provide a positive pressure on the nasopharynx and the oropharynx to keep the airways open therein allowing the user to continue to breathe. In this form of treatment, the patient wears a face mask over the mouth and nose while sleeping. The CPAP mask is connected to a CPAP hose that is connected to a flow generator of the CPAP device. The flow generator provides a continuous positive air flow to an airway of the patient, for example, nasal airway, mouth airway, at an elevated air pressure to treat the sleep apnea disorder. The CPAP mask communicates the CPAP hose with the airway of the patient. Examples of patient masks include, a nasal mask, nasal and oral mask, full face mask, nasal cannula, oral mouthpiece, tracheal tube, endotracheal tube, or hood.
The flow generator creates a continuous positive air flow of breathing gas having a pressure greater than the ambient atmospheric pressure. The continuous positive airway pressure system prevents the airway from closing or becoming obstructed during sleep. The CPAP device is adapted to use a continuous positive air pressure to the airway of the patient to treat sleep apnea disorders. The CPAP device, also, provides a positive pressure therapy in which the pressure of air delivered to the patient varies with the patient's breathing cycles or varies with the patient's effort to increase the comfort to the patient.
The air pressure from the continuous positive airway system is constant, and can be adjusted to best suit the individual's apnea condition. The air pressure in the continuous positive airway pressure system must be adjusted so that it maintains an open airway in the patient during all periods of sleep, but does not provide excessive pressure such that the device is bothersome to the patient.
Obstructive sleep apnea occurs when the upper airway becomes narrow as the muscles relax naturally during sleep. As noted above, this reduces oxygen in the blood and causes arousal from sleep. The CPAP device stops this phenomenon by delivering a stream of compressed air via a hose to a nasal pillow, nose mask, full-face mask, or hybrid, splinting the airway (keeping it open under air pressure) so that unobstructed breathing becomes possible, therefore reducing and/or preventing apneas and hyponeas. It is important to understand, however, that it is the air pressure, and not the movement of the air, that prevents the apneas. When the device is turned on, but prior to the mask being placed on the head, a flow of air comes through the mask. After the mask is placed on the head, it is sealed to the face over the patient's nose and or nose and mouth and the air stops flowing. At this point, it is only the air pressure that accomplishes the desired result. This has the additional benefit of reducing or eliminating the extremely loud snoring that sometimes accompanies sleep apnea.
The CPAP device through a flow generator blows air at a prescribed pressure (also called the titrated pressure). The necessary pressure is usually determined by a sleep physician after review of a study supervised by a sleep technician during an overnight study (polysomnography) in a sleep laboratory. The titrated pressure is the pressure of air at which most (if not all) apneas and hypopneas have been prevented, and it is usually measured in centimeters of water (cmH2O). The pressure required by most patients with sleep apnea ranges between 6 and 14 cmH2O. A typical CPAP device can deliver pressures between 4 and 20 cmH2O. More specialized units can deliver pressures up to 25 or 30 cmH2O. Other CPAP devices can titrate a range of continuous positive air pressure automatically based upon input entered into the CPAP device by the patient through a setting dial on the CPAP flow generator unit.
CPAP treatment can be highly effective in treatment of sleep apnea disorders. For some patients, the improvement in the quality of sleep and quality of life due to CPAP treatment will be noticed after a single night's use. Often, the patient's sleep partner also benefits from markedly improved sleep quality, due to the amelioration of the patient's loud snoring. Given that sleep apnea is a chronic health issue which commonly doesn't go away, ongoing care is usually needed to maintain CPAP therapy.
Continuous positive airway pressure systems remain the most effective treatment for sleep apnea. A concern with the CPAP device is that many patients, however, fail to use the CPAP device for treatment because they fall asleep before lodging the CPAP mask. Another concern is that an air pressure sensor is located at the CPAP hose or at the CPAP mask and can become completely blocked or partially blocked by a buildup of secretion from the patient in an exhaust port in the mask. Blockage can, also, occur as a result of the patient's bedding, covering the air pressure sensor. Therefore, for example, a patient using the CPAP device during a sleep cycle at night to treat sleep apnea can be interrupted. This leaves many sleep apnea patients without an effective treatment regimen.
Patient compliance with CPAP therapy is a significant issue. At the forefront of non-compliant issues is the condition of patients at bedtime. Many patients are usually fatigued and exhausted from lack of sleep and will usually fall asleep before turning the CPAP device on; or fall asleep before lodging the mask on his/her face to receive the necessary CPAP therapy.
Amongst the other issues, is the factor that the mask becomes dislodged during the user's sleep and, consequently, the user does not receive the necessary CPAP therapy. Many patients have difficulty tolerating the mask fitted to, the patient's face during an entire night of treatment for sleep apnea. Typically, the patient will experience a sleep arousal period or will partially awaken to move about during the night, and will return to sleep without reapplying the dislodged mask. Frequently, the mask will be remain partially or fully removed by the patient's movement during the night. The effectiveness of the CPAP treatment for sleep apnea is significantly disrupted after the mask is partially or fully dislodged during sleep or during a brief waking event. Data logging records, basic compliance information or detailed event logging, allowing the sleep physician (or patient) to download and analyses data recorded by the device to verify treatment effectiveness.
If the patient is not able to use the CPAP device properly for failure to lodge the mask or continued dislodgement of the mask during the sleep cycle, the patient will continue to suffer from sleep apnea disorders, not be able to receive relief and at risk of related physiological complications. In addition, the CPAP devices typically detect excessive mask disruptions, leaks due to mouth breathing in order to provide an electronic log of the total time the CPAP device is used by the patient, whether the patient was breathing normal, whether apnea events occurred, and whether open mouth breathing occurs during the sleep cycle. If the electronic log reveals non-compliance by the patient, it is possible that the patient's diagnosis of OSA, or CSA becomes questionable, which may result in loss of the prescribed CPAP device from the physician, or an insurance company's coverage of costs related to home treatment of the CPAP device.
Hence, a CPAP compliance notification apparatus and method is necessitated as a solution to the problems associated with the CPAP device and more importantly for implementation while the patient is awake or asleep.
Hence, to further maximize the effectiveness of sleep apnea treatment utilizing CPAP the CPAP compliance notification apparatus and method is needed to promote compliant use of the CPAP device and, therefore, to maximize CPAP treatment of apnea while the patient is awake prior to CPAP treatment or through a sleep cycle during CPAP treatment. It is embodied that a mat weight pressure sensor senses the presence of the patient recumbent or sitting in bed and starts the timer counting down to a pre-assigned delay-time off time and sounds the auditory buzzer which alerts the patient in the situation when the mask has not been initially lodged on his/her nose or mouth at the inception of sleep within the pre-assigned time limit.
The patient is alerted by an auditory alarm which reminds the non-sleeping patient, or wakens the sleeping patient to lodge the mask to start the CPAP treatment if in fact the patient has failed to lodge the mask within the preferred pre-set time limit. In addition, it is preferred that a pre-set timer with the buzzer provides a preferred timed alert notification to a patient when the mask has dislodged during sleep and, subsequently, when the patient has not reapplied the dislodged mask within the pre-set time limit. It can be beneficial to give the patient a time range to lodge the mask on his/her own before the alarm sounds and not to alert the alarm immediately. The alarm may be loud and wake others. As soon as the patient lodges the mask in the proper position on his/her face or nose the alarm will not be triggered. It can also be beneficial to give the patient a shorter time to lodge his/her mask within a shorter time limit.
A known patient preference is to read before he/she lodges the CPAP, or another known patient preference is to watch t.v. before the patient lodges the CPAP mask. However, one of the interfering factors is the fact that the sleep apnea patient is chronically fatigued because of lack of sleep due to his/her sleep apnea. As a result, the patient, frequently, is in bed, or in a recliner chair, or on an air mattress, or any sleep medium, and turns on the CPAP device with intentions to use the CPAP device for CPAP treatment, after reading or watching t.v. but falls asleep before the patient lodges his/her CPAP mask onto his/her nose or nose and/or mouth. The effectiveness of the CPAP treatment for the sleep apnea patient is obviously diminished if the mask is not initially lodged onto the patient's nose or mouth. If a patient is not alerted to the event of failure to initially lodge the mask then treatment for sleep apnea is, obviously, compromised.
In addition, when the patient is in bed and has successfully lodged his/her CPAP mask and falls asleep, the CPAP mask can become dislodged during the patient's sleep cylce. In this instance, the patient may not wake up to re-lodge his/her CPAP mask and once again the patient is non-compliant and, consequently, the patient does not receive his/her prescribed continuous positive air pressure therapy for his/her sleep apnea.
Accordingly, embodiments of the invention are provided that meet at least one or more of the following objects of the invention.
It is an object of an embodiment of the invention that the patient occupancy mat upon a patient's occupancy of the patient occupancy mat, for example, gets into bed in preparation to receive CPAP therapy, to automatically power the CPAP device to the “on-mode” and in simultaneous communication automatically starting a timer pre-assigned with a delay time within which an buzzer will sound to alert the patient in the event the patient has not lodged his/her CPAP mask, initially, while the patient was awake, or the CPAP mask has become dislodged during the patient's sleep cycle. It is known the patient can fall asleep before the patient turns on the CPAP device or the timer due to fatigue, or the patient simply forgets to turn on the CPAP device and as a result does not receive the necessary CPAP therapy. And, similarly, it is embodied that the mat weight sensor triggers the CPAP device to power to the “off mode” automatically when the patient vacates his/her bed and automatically turns off the timer in case the patient inadvertently forgets to do so.
It is another object of the embodiment of the invention to provide a patient occupancy mat sensor to detect the patient's occupancy in bed, and to provide a buzzer directly to alert the patient upon failure to initially lodge the mask, to alert the patient of mask misalignment, or mask dislodgement to maximize CPAP treatment of apnea through a sleep cycle.
A CPAP device was initially used mainly by patients for the treatment of sleep apnea at home. Today, patients are very transient. Therefore, it is another object of the embodiment of the invention to provide a CPAP compliance notification apparatus and method which includes a portable patient occupancy mat of varied sizes so that patient's occupancy can be detected on a variety of supportive substrate, including any one of bed mattress, wheel chair, bed, or in a recliner chair, or on an air mattress, or any sleep medium, or any seating medium
It is another object of an embodiment of the invention to provide a variety of assigned delay times thereby alerting the patient that his/her mask has not been initially lodged or is dislodged as soon as possible after dislodgement in order to have the mask refitted and to maximize CPAP treatment of apnea throughout the sleep cycle, or to alert the patient within a longer delay time that his/her CPAP has not been initially lodged or is dislodged so that the patient has time, for example, to watch t.v., read, or the like, or more time during his/her sleep-cycle before he/she is alerted to initially lodge his/her mask.
It is another object of the present invention to include a remotely positioned air pressure sensor remotely positioned from the air pressure being sensed from the air ways of the patient. The remote position of the air pressure sensor is advantageous because the air pressure sensor will not be dislodged when the patient moves during CPAP treatment and it will not become clogged with patient respiratory exudate from the patient's airways yielding incorrect air pressure signals.
It is another object of the present invention to include a remotely positioned reset button proximate to the patient.
The embodiment of the CPAP compliance notification device and method can be ascertained as mandatory of all CPAP users by physicians and insurance companies.